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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colonoscope And Accessories, Flexible/Rigid
510(k) Number K162330
Device Name Flex Robotic System and Flex Colorectal Drive
Applicant
Medrobotics Corporation
475 Paramount Drive
Raynham,  MD  02767
Applicant Contact John D. Bonasera
Correspondent
Medrobotics Corporation
475 Paramount Drive
Raynham,  MD  02767
Correspondent Contact John D. Bonasera
Regulation Number876.1500
Classification Product Code
FDF  
Date Received08/19/2016
Decision Date 05/04/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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